Appeals Court Nixes Cigarette Warnings

WASHINGTON -- A federal appeals court threw out the FDA's attempts to slap graphic warning labels on cigarette packs in a decision released Friday.

by David Pittman David Pittman,Washington Correspondent, MedPage Today
August 24, 2012

WASHINGTON -- A federal appeals court threw out the FDA's attempts to slap graphic warning labels -- such as a pair of lungs blackened by smoke -- on cigarette packs in a decision released Friday.

In the 2-1 decision, the U.S. Court of Appeals for the District of Columbia upheld a lower court ruling in March that cigarette companies' First Amendment rights would be violated by the warning labels. The court further ruled that the FDA failed to show the warning labels would reduce smoking.

"FDA has not provided a shred of evidence -- much less the 'substantial evidence' required by the [Administrative Procedure Act] -- showing that the graphic warnings will 'directly advance' its interest in reducing the number of Americans who smoke," the court wrote. "FDA makes much of the 'international consensus' surrounding the effectiveness of large graphic warnings, but offers no evidence showing that such warnings have directly caused a material decrease in smoking rates in any of the countries that now require them."

The regulation requires that starting on Sept. 22, cigarettes sold in the U.S. will have to carry graphic images warning of the dangers of smoking. These images include rotting teeth, diseased lungs, a baby enveloped in smoke, and a body on an autopsy table.

The images must be accompanied by such phrases as "cigarettes are addictive," "cigarettes cause cancer," and "smoking can kill you." They must be displayed on at least half of the front and back of cigarette packs, and 20% of the top of the pack.

But a group of four of the largest tobacco companies, including R.J. Reynolds, sued the FDA soon after it released the regulation. A federal judge issued an injunction barring the warning label regulation from taking effect until after further judicial review.

Friday's ruling contradicts another appellate decision -- that one from Cincinnati also in March -- that ruled the labels constitutional. The conflicting decisions could set up a Supreme Court case on the issue.

The Washington court called the FDA's reliance on data from Canada "underwhelming" when the agency tried to show that that country's use of graphic labels helped reduce smoking rates there.

Canada's smoking rate for those 15 and older went from 24% the year before labels were required to 21% two years later. But Canada also implemented other smoking controls at the same time.

"FDA's reliance on this questionable social science is unsurprising when we consider the raw data regarding smoking rates in countries that have enacted graphic warnings," the opinion read.

The court said the FDA can require companies to make "purely factual and uncontroversial" disclosures about the risks of their products, but stated that the graphic warnings crossed the line. "These inflammatory images and the provocatively-named hotline cannot rationally be viewed as pure attempts to convey information to consumers," the court said. "They are unabashed attempts to evoke emotion (and perhaps embarrassment) and browbeat consumers into quitting."

The American Cancer Society called the ruling disappointing saying warning labels, which haven't been updated in 25 years, need changing.

"Overwhelming evidence demonstrates both that existing warnings have failed to inform the public adequately of the risks of tobacco use, and that the large, graphic warnings required by the Family Smoking Prevention and Tobacco Control Act would be effective at raising public awareness of the risks of smoking," chief executive John R. Seffrin, PhD, said in a statement.

Martin L. Holton III, executive vice president and general counsel for R.J. Reynolds, said they are "committed to providing tobacco consumers with accurate information about the various health risks associated with smoking."

The case is R.J. Reynolds Tobacco Co et al v. FDA, U.S. Court of Appeals for the District of Columbia, No. 11-5332.